BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENVY G SERIES

    MDR report key: 20266093 · Received September 19, 2024

    Report

    Report Number
    MW5159741
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Report Date
    September 17, 2024
    Manufacturer
    AGILITI HEALTH - ELLIS
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    TWO (2) ENVYLINE G SERIES MATTRESSES COMPROMISED. REFERENCE REPORT: MW5159742.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1525635 ENVY G SERIES MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE FNM AGILITI HEALTH - ELLIS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown